Clinical development is an essential step in the drug development process. The complexity of this step is associated with a proper study designing to gain relevant data, a need to strictly follow all study procedures to generate reliable results, strong regulatory requirements, and a large magnitude of the cost involved. All those are applicable for any kind of clinical study, from early Phase I to post-marketing research.
Active CRO involvement in the early stages of drug development can bring many benefits to the Sponsor, particularly if it is a small company and does not have its own R&D.
This is a quite new area of our activities but already is rather successful. Clinical evaluation/investigation of medical devices is an essential process in their way to the commercial market. Having many similarities with the clinical trials for pharmaceuticals, those for medical devices have many differences in design and conducting.
Site Networks availability ensures a high-quality feasibility process, quick start, and effective projects management
■ ■ ■ CLS manages national and international networks of clinical sites in several therapeutic areas which allows us to minimize the start-up period. We have active Site Networks in the areas of Obstetrics & Gynecology, Internal Medicine, Oncology, Ophthalmology, Dermatology, Inflammation, and Surgery. In addition, we have established cooperation with a few advanced Phase I Units. ■ ■ ■